An Exercise Intervention to Reduce Fatigue in Rural Cancer Survivors
This clinical trial studies the effect of an exercise program on fatigue and fitness in rural cancer survivors. The exercise program uses different tools to keep track of fatigue and fitness progress and may result in improved fatigue and fitness for rural cancer survivors
Inclusion Criteria
- Adult (>= 18 years) cancer survivor * A maximum age of 80 will be set as virtual exercise may become unsafe as individuals get older
- A cancer diagnosis of any kind * CRF is a common symptom across cancer types and the current CRF reference chart was developed using data from patients with all cancer types.
- Current report of moderate-to-severe fatigue (> 3 on a 0-10 scale, per National Comprehensive Cancer Network [NCCN] definition)
- Live in rural Colorado and surrounding areas (> 1-hour commute to major front range city [Denver, Fort Collins, and Colorado Springs]) * This program attempts to target individuals in Colorado and surrounding areas with restricted access to fitness centers that may offer cancer specific services, most likely found in major front range cities. We have defined rural in terms of commute time to these cities, as it is the commute to these centers that restricts access
- Completed medical cancer treatment (chemotherapy and/or radiation) with curative intent within past 12 months or currently on treatment with no planned changes for the next 4 months (e.g. maintenance or palliative therapy). * No additional treatment planned for next 4 months * These restrictions are made to ensure the validity of tracking changes with the established reference chart, which was developed using data from cancer survivors who had recently completed therapy or were on therapy. It is unclear how fatigue response to exercise may change in survivors further out from treatment completion
- High-speed home internet and smartphone (or laptop with camera)
Exclusion Criteria
- Medical conditions that would impact the safety of, or participation in, an exercise program. This includes: * Orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries * Advanced rheumatoid arthritis * Widespread chronic pain conditions such as fibromyalgia * Significant balance impairment increasing the risk of falling * Pulmonary conditions such as chronic obstructive pulmonary disease, emphysema, interstitial lung disease, use of supplemental oxygen * Known cardiovascular disease, uncontrolled hypertension, or new cardiac event within the past 6 months
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04533165.
PRIMARY OBJECTIVES:
I. Determine the feasibility and preliminary effectiveness of the proposed exercise program.
Ia. Assess the enrollment rate of patients able and willing to participate in the program and the adherence of patients enrolled in the program to their prescribed exercise, cancer related fatigue (CRF) monitoring, and telehealth session participation.
Ib. Assess the effect of the proposed program on CRF improvements in enrolled participants and compare this effect to that of the supervised BfitBwell exercise program.
Ic. Assess the feasibility of the semi-continuous remote monitoring of fatigue (ecological momentary assessment) to better tailor the program to more acute changes in CRF. (Exploratory)
II. Assess participant perspectives of barriers and facilitators to participation in the prescribed exercise and CRF monitoring.
IIa. Gather qualitative data on barriers and facilitators to participation from all participants enrolling in the program using semi-structured interviews.
OUTLINE:
Patients participate in an exercise program for 12 weeks consisting of 2 mandatory exercise telehealth sessions and up to 5 triggered telehealth sessions over 1 hour each. Patients wear a fitness tracker on study.
After completion of study intervention, patients are followed up at 3, 6, and 12 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUCHealth University of Colorado Hospital
Principal InvestigatorRyan J. Marker
- Primary ID20-2015
- Secondary IDsNCI-2021-03964
- ClinicalTrials.gov IDNCT04533165